Licensee Patent Validity Challenges Following MedImmune: Implications for Patent Licensing

This Article addresses the legal basis for resolving the licensor’s dilemma following MedImmune.  The MedImmune Court’s elimination of the jurisdictional barrier to a patent validity challenge by a licensee in good standing has been viewed by many as a pronounced shift in favor of the licensee in the balance of rights between licensor and licensee in patent license agreements.  Moreover, the Court’s ruling has given rise to a dilemma for patent licensors, namely, how to redress the shift in the balance of rights.  Specifically, the questions to be answered are as follows: (1) Is there a vestige of the doctrine of licensee estoppel to protect a patent licensor from a validity challenge by a licensee in good standing, and (2) if one cannot rely on the doctrine, are explicit contract provisions that prohibit, reduce the incentive for, and/or specify a consequence of, a licensee’s challenge of the validity of a licensed patent enforceable?

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Provigil: A Case Study Of Anticompetitive Behavior

Using the sleep-disorder drug Provigil as a case study, this article exposes a new type of anticompetitive harm that stems from the combination of two distinct activities.  First, brand-name drug firms such as Cephalon, the developer of Provigil, have settled patent litigation by paying generic firms to delay entering the market.  Second, brand firms, frequently at the end of a patent term, have engaged in “product hopping,” switching from one means of administering a drug (e.g., tablet) to another (e.g., capsule).  The story of Provigil demonstrates the anticompetitive harm that can result from the combination of these two activities.

 by Michael A. Carrier*

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Provigil: A Commentary

Michael Carrier’s case study on Provigil offers new support for the view that Big Pharma is to blame for stymieing competition, retarding innovation, and inflating prices in the drug industry. Carrier argues that Cephalon was able to thwart generic entry by a combination of anticompetitive strategies. It entered into a reverse payment settlement agreement with generics seeking to enter the market. Having already spilled considerable ink on the patent settlements issue. I will focus my commentary on Carrier’s “product hopping” claims—essentially, that Cephalon rolled out Nuvigil merely to thwart competition. Since I have no expertise with the relevant products and no particular dog in the fight between Cephalon and its antagonists, I limit myself to three very general observations about the case study and its ostensible morals for public policy.

by Daniel A. Crane*

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Branded Versus Generic Competition?

 Transitions are times of danger in virtually all areas of human life.  More accidents are likely to occur when cars go in and out of parking spaces, or when planes take off or land. More medical mishaps are likely to happen in hospitals when there is a change in shifts between nurses.  The same pattern holds in the law of pharmaceutical patents, during the transition from a fully proprietary regime to one that allows for as many firms as possible to market a generic version of a once-protected pharmaceutical patent.To pass judgment on these issues, it is often necessary to ask the thankless question of whether the supposed advances in science exceed the preclusive effect that arises if the original product is removed from the Orange Book—or official FDA registry of drugs available for sale—in ways that limit competition.

by Richard A. Epstein*

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The Geosynchronous Orbit and the Outer Limits of Westphalian Sovereignty

The question confronting us today is: who  owns the GSO?  The inevitability of technological and scientific progress promises a future full of challenges for  space lawyers, who will ultimately be responsible for the composition of (and adherence to) international law in this new frontier.  In this Note, I will explore a topic that may initially seem like a plot out of Star Trek, but is very much real, and will become even more relevant as humanity ventures farther from home.

In recent years, “parking spots” in the geosynchronous orbit have become an increasingly hot commodity.  According to the National Aeronautics and Space Administration (NASA), since the launch of the first television satellite into a geosynchronous orbit in 1964, the number of objects in Earth’s orbit has steadily increased to over 200 new additions per year.  This increase was initially fueled by the Cold War, during which space was a prime area of competition between the United States and the Soviet Union.  Yet over two decades after the end of the US-Soviet space race, even the global financial crisis that began in 2007 does not seem to have diminished the demand for telecommunications satellites positioned in GSO.  This ongoing scramble to place satellites in GSO prompted some developing equatorial countries to assert sovereignty over the outer space “above” their territorial borders, presumably with the hope of extracting rent from the developed countries that circulate their technologies overhead.  So far, the international community has rejected this notion, but the legal status of the GSO remains in limbo.

by Nima Nayebi*

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